Trial Outcomes & Findings for Evaluation of the Duration of Therapy for Thrombosis in Children (NCT NCT00687882)
NCT ID: NCT00687882
Last Updated: 2025-06-18
Results Overview
Occurrence of symptomatic recurrent venous thromboembolism. Primary safety endpoint is occurrence of clinically-relevant bleeding (major + clinically-relevant non-major) bleeding.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
532 participants
Primary outcome timeframe
1 Year
Results posted on
2025-06-18
Participant Flow
This is as per "parallel-cohort RCT design" that certain patient subgroups specified a priori, who don't meet post-enrollment randomization criteria (randomization being at 6 weeks post-enrollment) were allocated to parallel cohort arms (observational non-randomized) for continued follow-up in the study, and for prespecified analysis separately from the RCT population.
Participant milestones
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
207
|
210
|
76
|
39
|
|
Overall Study
COMPLETED
|
175
|
178
|
76
|
39
|
|
Overall Study
NOT COMPLETED
|
32
|
32
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
More than one race includes "other"
Baseline characteristics by cohort
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=207 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=210 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
n=76 Participants
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
n=39 Participants
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
Total
n=532 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
200 Participants
n=5 Participants
|
198 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
510 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
8.7 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
8.5 years
STANDARD_DEVIATION 6.8 • n=7 Participants
|
5.6 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
9.6 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
8.3 years
STANDARD_DEVIATION 6.8 • n=21 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
249 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
110 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
283 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • More than one race includes "other"
|
1 Participants
n=7 Participants • More than one race includes "other"
|
1 Participants
n=5 Participants • More than one race includes "other"
|
0 Participants
n=4 Participants • More than one race includes "other"
|
2 Participants
n=21 Participants • More than one race includes "other"
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants • More than one race includes "other"
|
6 Participants
n=7 Participants • More than one race includes "other"
|
3 Participants
n=5 Participants • More than one race includes "other"
|
1 Participants
n=4 Participants • More than one race includes "other"
|
16 Participants
n=21 Participants • More than one race includes "other"
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • More than one race includes "other"
|
0 Participants
n=7 Participants • More than one race includes "other"
|
0 Participants
n=5 Participants • More than one race includes "other"
|
0 Participants
n=4 Participants • More than one race includes "other"
|
0 Participants
n=21 Participants • More than one race includes "other"
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants • More than one race includes "other"
|
29 Participants
n=7 Participants • More than one race includes "other"
|
10 Participants
n=5 Participants • More than one race includes "other"
|
2 Participants
n=4 Participants • More than one race includes "other"
|
69 Participants
n=21 Participants • More than one race includes "other"
|
|
Race (NIH/OMB)
White
|
151 Participants
n=5 Participants • More than one race includes "other"
|
146 Participants
n=7 Participants • More than one race includes "other"
|
57 Participants
n=5 Participants • More than one race includes "other"
|
31 Participants
n=4 Participants • More than one race includes "other"
|
385 Participants
n=21 Participants • More than one race includes "other"
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=5 Participants • More than one race includes "other"
|
12 Participants
n=7 Participants • More than one race includes "other"
|
0 Participants
n=5 Participants • More than one race includes "other"
|
0 Participants
n=4 Participants • More than one race includes "other"
|
18 Participants
n=21 Participants • More than one race includes "other"
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=5 Participants • More than one race includes "other"
|
16 Participants
n=7 Participants • More than one race includes "other"
|
5 Participants
n=5 Participants • More than one race includes "other"
|
5 Participants
n=4 Participants • More than one race includes "other"
|
42 Participants
n=21 Participants • More than one race includes "other"
|
|
Region of Enrollment
Canada
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Region of Enrollment
Austria
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
203 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
520 Participants
n=21 Participants
|
|
Region of Enrollment
Israel
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 YearPopulation: Per protocol population analysis
Occurrence of symptomatic recurrent venous thromboembolism. Primary safety endpoint is occurrence of clinically-relevant bleeding (major + clinically-relevant non-major) bleeding.
Outcome measures
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=154 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=143 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
n=76 Participants
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
n=39 Participants
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Efficacy Outcome - Occurrence of Symptomatic Recurrent Venous Thromboembolism
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Per-protocol population used for this analysis
Occurrence of clinically-relevant (i.e. major plus clinically-relevant non-major (CRNM) bleeding
Outcome measures
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=154 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=143 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
n=76 Participants
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
n=39 Participants
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Safety Outcome - Occurrence of Clinically-relevant (i.e. Major Plus Clinically-relevant Non-major (CRNM)
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Per protocol analysis, data not collected in the parallel cohorts.
Occurrence of symptomatic recurrent venous thromboembolism (VTE) or development of Post Thrombotic Syndrome (PTS) (composite endpoint)
Outcome measures
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=120 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=108 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Efficacy Outcome 1 - Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE) or Development of Post Thrombotic Syndrome (PTS) (Composite Endpoint)
|
36 Participants
|
32 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Outcome events for patients with symptomatic recurrent VTE in the ITT population. Per protocol analysis, data not collected in the parallel cohorts
Occurrence of symptomatic recurrent venous thromboembolism (VTE) in the intention to treat (ITT) population.
Outcome measures
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=207 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=210 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Efficacy Outcome 2 - Occurrence of Symptomatic Recurrent Venous Thromboembolism (VTE)
|
3 Participants
|
5 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Per-protocol population analysis, data not collected in the parallel cohorts
Development of Post Thrombotic Syndrome (PTS)
Outcome measures
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=120 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=108 Participants
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Efficacy Outcome 3 - Development of Post Thrombotic Syndrome (PTS)
|
35 Participants
|
32 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
Serious events: 11 serious events
Other events: 54 other events
Deaths: 4 deaths
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
Serious events: 20 serious events
Other events: 65 other events
Deaths: 4 deaths
Parallel Cohort: Persistent Occlusive Thrombosis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Parallel Cohort: Persistent Antiphospholipid Antibody
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=207 participants at risk
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=210 participants at risk
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Congenital, familial and genetic disorders
Microvillous inclusion disease
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Haematemesis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Haematochesia
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Fatigue
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Pyrexia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Bronchiolitis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Pneumocystic joroveci pneumonia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Viral infection
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Gram stain positive
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Status epilepticus
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.48%
1/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Surgical and medical procedures
Adenotonsillectomy
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
Other adverse events
| Measure |
Intervention: A (Shortened Duration (6 Weeks) of Anticoagulant Therapy)
n=207 participants at risk
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Shortened duration (6 weeks) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 6 weeks.
|
Intervention: B (Conventional Duration (3 Months) of Anticoagulant Therapy)
n=210 participants at risk
Patients with non-occlusive thrombus or resolved thrombosis at 6 weeks.
Conventional duration (3 months) of anticoagulant therapy: Subjects with evidence of non-occlusive or resolved thrombus at 6 weeks time will be randomized to receive a total duration of anticoagulant therapy of 3 months.
|
Parallel Cohort: Persistent Occlusive Thrombosis
Patients with completely occlusive thrombosis at 6 weeks.
No Intervention: Subjects with evidence of persistent thrombus at 6 weeks time will remain on anticoagulant therapy for 3-6 months at the discretion of their treating physician.
|
Parallel Cohort: Persistent Antiphospholipid Antibody
Patients with persistent Positive Antiphospholipid Antibody at 6 weeks.
No Intervention: Subjects with evidence of persistent antiphospholipid antibody at 6 weeks will remain on anticoagulant therapy for 3 months to indefinite duration, at the discretion of their treating physician.
|
|---|---|---|---|---|
|
Infections and infestations
Enterovirus infection
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Gastric infection
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Cardiac disorders
Splenomegaly
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Cardiac disorders
Tachycardia
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Congenital, familial and genetic disorders
Congenital cystic kidney disease
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Congenital, familial and genetic disorders
Microvillous inclusion disease
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Congenital, familial and genetic disorders
Thyroglossal cyst
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Eye disorders
Eye swelling
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Eye disorders
Papilledema
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Eye disorders
Vision blurred
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.9%
4/207 • Number of events 5 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
1.9%
4/210 • Number of events 4 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Diarrhea
|
1.4%
3/207 • Number of events 3 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Hematemesis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Hematochezia
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Lip swelling
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Teething
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Toothache
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
5/207 • Number of events 5 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
2.4%
5/210 • Number of events 5 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Chest discomfort
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Chest pain
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Fatigue
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Injection site hematoma
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
1.4%
3/210 • Number of events 3 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Injection site pain
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 3 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Injection site swelling
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Edema peripheral
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
General disorders
Pyrexia
|
1.9%
4/207 • Number of events 4 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
3.3%
7/210 • Number of events 7 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Immune system disorders
Seasonal allergy
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Abscess
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Bronchiolitis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Celluitis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Dermatitis infected
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Ear infection
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Gonorrhea
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Implant site cellulitis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Infection
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
1.4%
3/207 • Number of events 3 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Influenza
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Nasopharyngitis
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
2.4%
5/210 • Number of events 6 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Oral candidiasis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Scrotal abscess
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Sepsis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Sinusitis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.9%
6/207 • Number of events 6 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Vaginitis bacterial
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Infections and infestations
Viral infection
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Fall
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Albumin globulin ratio increased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Blood osmolarity decreased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
C-reactive protein increased
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Globulins decreased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Gram stain positive
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
International normalized ratio decreased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
Transaminases increased
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Hyperkaliemia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.4%
3/207 • Number of events 4 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.9%
4/207 • Number of events 4 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
1.4%
3/210 • Number of events 5 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Musculoskeletal and connective tissue disorders
Weight bearing difficulty
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Cerebral hemorrhage
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Dizziness
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Headache
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
1.9%
4/210 • Number of events 5 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Migraine
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Nervous system disorders
Status epilepticus
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Psychiatric disorders
Depression
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Renal and urinary disorders
Dysuria
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Renal and urinary disorders
Renal failure
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Reproductive system and breast disorders
Dysmenorrhea
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
3/207 • Number of events 3 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
1.9%
4/210 • Number of events 4 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.97%
2/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.97%
2/207 • Number of events 3 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.95%
2/210 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Hemoptysis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.48%
1/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
0.48%
1/207 • Number of events 2 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Skin hemorrhage
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Skin and subcutaneous tissue disorders
Subcutaneous hematoma
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Surgical and medical procedures
Abscess drainage
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Surgical and medical procedures
Adenotonsillectomy
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Surgical and medical procedures
Ileostomy closure
|
0.48%
1/207 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.00%
0/210 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Vascular disorders
Peripheral embolism
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/207 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
0.48%
1/210 • Number of events 1 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
—
0/0 • From randomization up to 12 weeks plus 10 days post-diagnosis
Adverse Events, Serious Adverse Events and All Cause Mortality were collected from time of randomization to the end of the 12-week study window (12 weeks plus 10 days post-diagnosis). AEs were not collected on those patients who are assigned to a parallel cohort group or withdrawn prior to randomization.
|
Additional Information
Dr. Neil A Goldenberg, Associate Dean of Research
Johns Hopkins All Children's Hospital
Phone: 727-767-3674
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place